Efficacy and Safety Analysis of ICIs Plus Angiogenesis Inhibitors for Treatment of Advanced NSCLC in Elderly Patients (IMAGINE)

Nanjing Medical University

Status: Completed

Conditions: NSCLC

Treatments: Drug: Immune checkpoint inhibitors without angiogenesis inhibitors; Drug: Immune checkpoint inhibitors plus angiogenesis inhibitors

Study type: Observational

Funder types: Other

Identifiers

NCT05688046

IMAGINE

Details and patient eligibility

About

Immune checkpoint inhibitors(ICIs) combined with angiogenesis inhibitors may is synergistic in elderly patients with advanced non-small cell lung cancer(NSCLC), however its true efficacy is still unclear. The investigators retrospectively compared clinical efficacy and safety of driver-negative elderly patients with advanced NSCLC treated with ICIs with(or without)angiogenesis inhibitors in the Cancer Center of the Affiliated Suzhou Hospital of Nanjing Medical University.

Full description

The investigators reviewed the medical records of all lung cancer patients in the Cancer Diagnosis and Treatment Center of Suzhou Hospital Affiliated to Nanjing Medical University from January 1, 2019 to December 31, 2021, and a total of 79 patients were enrolled. The subjects were divided into two groups: the group treated with immune checkpoint inhibitors plus antiangiogenic drugs(IA group) and the group treated with immune checkpoint inhibitors without antiangiogenic drugs(NIA group). The data of PFS, OS, ORR, covariates, and Immune-related adverse events (irAEs) were collected through electronic medical records and follow-up. The primary endpoint of the study was PFS, and the secondary endpoints were OS, ORR and irAEs.All enrolled patients were followed up until August 1, 2022.

Enrollment: 79 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Age ≥65 years old.
2. Stage IV according to the AJCC Cancer grading manual (8th edition).
3. Histologically confirmed NSCLC.
4. No driver mutations.
5. Received at least 2 courses of immunotherapy.
6. Expected survival time > 3 months.
7. No concurrent malignancy.
8. Not participating in a clinical trial.
9. The functions of important organs were basically normal.
10. Sign informed consent.

Trial design

79 participants in 2 patient groups

IA group

Description:

Immune checkpoint inhibitors plus angiogenesis inhibitors group

Treatment:

Drug: Immune checkpoint inhibitors plus angiogenesis inhibitors

NIA group

Description:

Immune checkpoint inhibitors without angiogenesis inhibitors group

Treatment:

Drug: Immune checkpoint inhibitors without angiogenesis inhibitors